| Product Name: | Alpha Beta Arteether Injection 150mg/2ml (Arachis oil Injection) |
| Brand Name: | Artemotial |
| Strength: | 75mg/ml, 150mg/2ml |
| Dosage Form: | Liquid Injection (Ampoule) |
| Packing: | 1 mL, 2 mL, 3 mL |
| Route of Administration: | For Intramuscular use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antimalarials, Antiparasitic |
| Indication: | Useful in severe malaria including cerebral malaria & as a second line treatment in chloroquine resistant malaria cases only. |
| Storage: | Store at 20° to 25°C. Do not allow to freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Alpha Beta Arteether Injection 75mg/ml
- Alpha Beta Arteether Injection 150mg/2ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Alpha Beta Arteether Injection 75mg/ml
Each 2ml contains:
α- β arteether…………75mg
Arachis oil BP…………………. q.s. - Alpha Beta Arteether Injection 150mg/2ml
Each 2ml contains:
α- β arteether…………150mg
Arachis oil BP…………………. q.s.
THERAPEUTIC INDICATION:
Useful in severe malaria including cerebral malaria & as a second line treatment in chloroquine resistant malaria cases only.
PACKING:
75mg/ml (150mg/2ml, 225mg/3ml)
DIRECTION OF USE:
For Intramuscular use only.
See insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: The drug should not be promoted or used as a first line treatment for malaria. Do not use if any particle/suspended matter is visible.
Discard any unused product immediately after use.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C. Do not allow to freeze. Protect from light.
Dosage:Adult: 150mg i.e., 1 ampoule of α/β arteether once daily for 3 consecutive days.
Children: 3mg/kg per day administered by intramuscular injection over a 3-day period.
Deep intramuscularly in the upper lateral quadrant of the buttock. No other drug should be mixed in the same syringe.